For more than four years, Lynn Milam's life was bound by the pain that radiated from her swollen joints.
"My children could not hug me," she says. "I couldn't hold my husband's hand."
Milam also couldn't climb stairs or help raise her teenage son. She spent most days on the couch.
The reason was rheumatoid arthritis, which occurs when the immune system starts attacking the lining of joints.
Milam tried everything: physical therapy, acupuncture, steroids, and even the latest immune drugs. Nothing worked.
That changed in October of 2023, when a surgeon implanted an experimental device in Milam's neck. For a minute each morning, it delivers pulses of electricity to her vagus nerve, which connects the brain with internal organs.
"Three weeks in, my elbow pain was completely gone," she says. "Then my hands didn't hurt anymore, the swelling started going away."
Eventually, all symptoms of rheumatoid arthritis had vanished. Milam, 60, says she and her husband have regained the life they enjoyed before she got sick.
"It's like a rebirth," she says.
And now, the device will be available to many other people like Milam.
In July, the Food and Drug Administration approved the device, made by SetPoint Medical, for people with rheumatoid arthritis whose symptoms aren't adequately controlled by drugs.
On Aug. 22, surgeons at Northwell Health in New York implanted the first approved device in a patient.
The FDA approval could be a turning point for the treatment of not only rheumatoid arthritis, but other autoimmune diseases, including multiple sclerosis and inflammatory bowel disease.
"This treatment is using the body's own mechanism of managing inflammation," says Dr. John Tesser, a rheumatologist in Phoenix who oversaw the study that led to the device's approval.
By stimulating the vagus nerve, the device sends a signal to the hypothalamus, a brain area that regulates bodily functions and interacts with the immune system. That brain area responds by sending signals back down the vagus nerve to the spleen.
The signals instruct certain cells in the spleen to slow down production of proteins called cytokines, which regulate inflammation, including inflammation in the joints. Cytokines play an important role in fighting infection, but can also trigger damage to healthy tissues, including the lining of joints.
The device rarely produces the sort of dramatic recovery that Lynn Milam experienced. But the pivotal clinical trial found that patients who had not responded to even the most powerful drugs often saw meaningful improvement.
"Thirty-five percent of the patients did achieve that in this very difficult-to-treat group," Tesser says. That was significantly more than in a comparison group whose stimulators had not yet been switched on.
The entire process is initiated by an implant "the size of a lima bean," says Dr. Peter Konrad, chair of neurosurgery at the Rockefeller Neuroscience Institute at West Virginia University. "Everything's all built on a little chip and then it's contained in a little silicon jacket."
The outpatient surgery to implant the device is straightforward for any surgeon who has implanted vagus nerve stimulators often used to control epileptic seizures, Konrad says.
"I've had dental surgery that was more of a process than this surgery was," Milam says.
After the surgery, though, there was a hitch.
Because the device sits so close to the vocal chords, Milam's voice was temporarily limited to a whisper. A second procedure fixed that, but left her voice slightly lower than it had been.
Milam says she'll accept that for a treatment that did what drugs couldn't.
The stimulator has restored her ability to climb stairs, cook, and travel, she says.
Her husband, Donald Milam, says it's also allowing the couple to do things together again.
"Walking the dogs, holding hands — just the simple things," he says. "And hugs."
Copyright 2025 NPR
